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13 May 2019 | Story Zama Feni | Photo Charl Devenish
Dr Quinton Meyer and Marlena Visagie
National Control Laboratory Deputy Director, Dr Quinton Meyer (right), and Marlena Visagie, Quality Assurance Manager, at the laboratory within their facilities at the University of the Free State.
The University of the Free State-based National Control Laboratory for Biological Products (NCL) has maintained its esteemed status as a pharmaceutical testing laboratory after the South African Accreditation System (SANAS) further endorsed its quality-management systems as of high standard according to the International Standards Organisation’s requirements.

The Director of the NCL, Professor Derek Litthauer, said their laboratory – which is also approved by the World Health Organisation (WHO) – has again achieved the international testing standards. The cherry on top was that the NCL also received a certificate of Good Manufacturing Compliance (GMP) from the South African Health Products Regulatory Authority (SAHPRA). 

NCL is for Africa and the World 

Some of the factors that make the NCL an esteemed institution, is the fact that it is one of 12 laboratories worldwide to perform vaccine testing for the WHO; the NCL is the only vaccine-testing laboratory in the country that performs the final quality-control testing of all human vaccine batches marketed in South Africa on behalf of SAHPRA. 

For example, Prof Litthauer said that the influenza vaccine batches currently available on the South African market, were tested by the NCL for quality before authorising their release for sale to the public. This process is followed for all human vaccines used in SA.

 “In our role as vaccine-testing laboratory for the WHO, the NCL helps to ensure that the vaccines purchased through the WHO prequalification programme for international distribution to resource-limited countries, meet the high standards of quality, safety, and efficiency. 
The NCL was one of the first full members of the WHO NCL Network for Biologicals, which consists of full and associate members of regulatory authorities from more than 30 countries.

The NCL systems are world-class

Prof Litthauer said this achievement is recognition that their laboratory complies with specific international standards with respect to its quality-management system. 
“In practice, it means that the laboratory has all the quality systems in place to ensure high-quality test results. The GMP certification is a further step, meaning that laboratory testing is on the expected level for any pharmaceutical testing laboratory and manufacturer. It is a very strict certification.”

He further mentioned that the NCL is also licensed as a pharmaceutical manufacturer. “Although we do not manufacture, we have to comply with manufacturing standards.”
“It is rare for a pharmaceutical testing laboratory (such as the NCL) outside of a manufacturing context to qualify for both certifications. It means that the NCL complies with exceptionally strict standards for pharmaceutical labs anywhere in the world,” he said.
The certification provides the South African Health Products Regulatory Authority, the World Health Organisation, and other national control laboratories around the world, with the confidence that the test results from the NCL can be trusted.


There can be no compromise for quality 

The NCL Quality Assurance Manager, Mrs Marlena Visagie, said, “It is essential that the NCL complies with the highest international quality-assurance standards to ensure that all the lot-release operations, such as manufacturing review and quality testing, are performed in a reliable and reproducible manner.”

“There can be no compromise when it comes to the quality of medicines which are made available to the public,” she said.

“What makes this special, is that the NCL does not only comply with international ISO/IEC standards for pharmaceutical testing, but also with the additional GMP standards required by a pharmaceutical manufacturer. This means that the NCL must ensure that all its operations, including everything from the way documents are compiled and stored, to the maintenance of equipment and infrastructure as well as staff competency, are performed according to international guidelines.”

All NCL staff share vision of excellence

Prof Litthauer said the NCL has a staff complement of 15 technical, administrative, and support staff.  Four staff members have PhDs, and the rest of the technical staff have master’s or bachelor’s degrees or are trained as medical technologists. “At the moment, our biggest problem is to get enough suitable space to expand our testing,” he said.

Prof Litthauer said, “All the staff members at the NCL share the vision of excellence, which makes this kind of achievement possible.”
The NCL will host the third annual meeting of the WHO NCL Network in November of this year and will then be reassessed again by the WHO as part of the normal three-year cycle of assessments.  

News Archive

Central SRC constitution for UFS approved by Council
2005-07-20

University of the Free State Fact Sheet

1. The Council of the University of the Free State (UFS) on 10 June 2005 unanimously approved the establishment of a Central Student Representative Council (CSRC)  to constitute a legitimate basis for the democratic participation of students of all three of its campuses in the governance of the university.

2. In a major breakthrough and transformation step for student governance, the Central SRC will include representatives of the main campus in Bloemfontein, the Vista Bloemfontein campus and the Qwaqwa campus of the UFS.

3. The need to establish the Central SRC follows the incorporation of the Qwaqwa campus into the UFS in January 2003 and the incorporation of the Vista campus in Bloemfontein into the UFS in January 2004.

4. The constitution of the Central SRC is the outcome of a consensus reached during a lengthy process of negotiation between the SRCs of the three UFS campuses, indirectly involving diverse student formations such as Sasco, ANCYL, YCL, Pasma, SASO, SADESMO, AZASCO, SCO, HEREXVII, KovsieAlliance, ACDP, etc. Independent constitutional and political experts facilitated key parts of the negotiation process.

5. In this process, the UFS management went out of its way to ensure the participation of all student formations, especially Sasco and the ANC Youth League, as well as the duly elected SRC officials of the three campuses.

6. With the establishment of a Central SRC, the UFS has adopted a federal student governance model whereby the CSRC is the highest representative student body on matters of common concern for all students. The three campuses of the UFS will retain SRC structures for each campus with powers and responsibilities for matters affecting the particular campus.

7. The central SRC will have 12 members made up of delegates of the different campus SRCs, including the presidents of these three SRCs. In total, the main campus will have 5 representatives, the Qwaqwa campus will have 4 representatives and the Vista campus will have 3 representatives. This ratio ensures a strong voice for the smaller campuses in the central SRC.

8. This arrangement will be reviewed after a year to make allowance for the phasing out of undergraduate (pipeline) students at the Vista campus, as was agreed in the negotiations preceding the incorporation of that campus into the UFS.

9. From these 12 members a central SRC president will be chosen on a quarterly basis to represent the general student body at Executive Management, Senate and Council.

10. The historic official inauguration of the first Central SRC is scheduled to take place in early August 2005.

11. This event, like the adoption of a broadly negotiated new constitution for the main campus SRC, represents a  breakthrough in that all three campus SRCs delegations and all relevant student organizations have been part of the process and have accepted the outcome of the process.

20 July 2005

 

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